Optimal Dosing of IC-Green for Visualization of Rotator Cuff Vascularity Using Advanced Imaging Modality Arthroscopy

Completed · Phase 1

Conditions studied: Rotator Cuff Tears

In brief

Rotator cuff re-tear is a common delayed complication of arthroscopic rotator cuff repair. This process of re-tear is multifactorial and there has not been any readily identifiable perioperative measure that is predictive of subsequent rotator cuff failure. There have been no human studies looking at intraoperative assessment of rotator cuff vascularity, nor the predictive value that vascularity may have for rotator cuff re-tear. Indocyanine Green (ICG) has been safely used in patients for visualization purposes and has real potential for identifying vascularity in arthroscopic surgical patients. The aim of this study is to establish a standard dosing protocol for ICG in the arthroscopic visualization of rotator cuff vascularity.

Key facts

Study ID

NCT04340752

Run by

NYU Langone Health

People needed

20

Starts

2021-01-27

Expected to finish

2025-09-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients has full or partial thickness rotator cuff tear and is scheduled to undergo arthroscopic rotator cuff repair
• Patient is at least 18 years of age and less than 80 years of age

You may not qualify if…

• Patient is less than 18 years of age or greater than 79 years of age
• Patient has a documented allergy to iodides
• Patients who have had iodide based radiology studies within the last seven (7) days prior to surgery
• Patient is pregnant

Where it is running

• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

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